Methods for treating sleep disorders, sleep disturbances, and related symptoms using aminosterol compositions

Abstract

This invention relates to methods of treating or preventing a sleep disorder, sleep disturbance, or related symptom in a subject with aminosterols or pharmaceutically acceptable salts or derivatives thereof. In particular, the disclosed methods generally comprise administering an aminosterol to a subject in need, thereby stimulating an aminosterol-induced CNS response to treat and/or prevent a sleep disorder, sleep disturbance, or related symptom.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims priority of U.S. Provisional Patent Application No. 62 / 556,164, filed on Sep. 8, 2017, the contents of which are incorporated herein by reference in their entirety.FIELD OF THE INVENTION[0002]This application relates to methods of treating, preventing, or improving sleep disorders and / or sleep disturbances, or related symptoms, in human subjects. The method comprises administering to a subject in need thereof an aminosterol, or a salt or derivative thereof.BACKGROUND OF THE INVENTION[0003]Squalamine is a unique compound with a structure that was not previously seen in nature, being a bile acid coupled to a polyamine (spermidine):[0004]The discovery of squalamine, the structure of which is shown above, was reported by Michael Zasloff in 1993 (U.S. Pat. No. 5,192,756). Squalamine was discovered in various tissues of the dogfish shark (Squalus acanthias) in a search for antibacterial agents. The most abundant source of...

AI Technical Summary

Benefits of technology

[0027]The present invention is directed to methods of treating and / or preventing sleep disorders, sleep disturbance, or related symptom in a subject. The method comprises administering a composition comprising a pharmaceutically acceptable grade of at least one aminosterol, or a pharmaceutically acceptable salt or derivative thereof, in an amount sufficient to produce a beneficial effect to a subject in need. Suitable “aminosterols” are described herein, and include for example squalamine or a pharmaceutically acceptable salt or derivative thereof, Aminosterol 1436 or a pharmaceutically acceptable salt or derivative thereof, or an aminosterol isolated from Squalus acanthias or a pharmaceutically acceptable salt or derivative thereof. The composition can comprise one or more pharmaceutically acceptable carriers. For the purposes of this application, the subject is generally human.

Problems solved by technology

Squalamine is also marketed under the brand name Squalamax™ as a dietary supplement, though it has not been approved as a drug in this form and thus cannot make therapeutic claims.

Aminosterol 1436, although capable of inducing weight loss when administered parenterally to dogs, and rodents exhibited no anorectic activity when administered orally, consistent with its poor bioavailability when delivered orally.

Indeed, in a published review on the applications of squalamine as a therapeutic, Genaera scientists state “Although squalamine lactate is well absorbed in rodents by the subcutaneous and intraperitoneal routes, preliminary studies indicate that it is poorly bioavailable orally.” (Connolly et al.

This resulted in generally accepted conclusions by those skilled in the art of drug development that aminosterols could not provide any benefit for systemic conditions when administered orally.

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